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Quality assurance of sterility test fo厭可r medicinal glass bottles Release time: 202站數0-08-23 Visited: 1636 Times

The most important quality assurance o地黃f medical glass bottle depends on ste可雜rility test. In this regard, a good as謝理eptic testing packaging is i費站ndispensable.


The risk of sterility test o區家f medical glass 秒子bottles generally comes from t錢綠he following co錢去ntents:


1、 The following ar廠能e the credibility of sterilizati市朋on process; 2. The enviro離街nmental pollution le電他vel of microbial strains of ra水樂w materials; 3. Whether a sound a老些septic testing assurance sys鐘車tem management has been formul笑短ated; 4. Whethe輛算r a sound aseptic testin內熱g assurance system management has be外呢en formulated; 4;


Then, to ensure the sterility test of做花 medical glass bottles, we must star行時t from the following contents:


1. Effective sterilizatio地校n methods should be selected, which還大 can exceed the actual effect of鐘計 complete sterilization. Generally spe讀的aking, ethylene oxide st唱亮erilization or cobalt 60 steriliza劇技tion method should be used for ste一著rilization. 2. To舞生 test the environmental pollu兒地tion level of raw materia樂鐘ls, generally speaking, the sprea自些d of microbial strains i門黑n solid raw materials will not be symme鐘土trical, resulting in the test r看視esults may not necessarily mean th你作e overall situation of t員工he whole batch of raw m舞遠aterials. Relevant 什西purchase specifications of ra司近w and auxiliary materials should be現船 formulated, an玩票d the relative microbial strain鄉兒 level should be required. 3. Se愛區lect excellent processing technolog關藍y to carry out manufactur要秒ing to ensure the excellent seal司購ing performance of the b相河ottle body, and s雜是elect the matching cap with good seali理靜ng performance, so as to reasonably en風鄉sure the sealing.行飛 4. Formulate and impro開事ve the aseptic testing system managem一為ent to ensure that 會雨the environment of the 民內production workshop and the關西 relevant specifications of the 地愛purification workshop exceed the pro年作visions of GMP and 從些the company's化靜 own specifications黑笑.